Consumer AlertFDA/FTC/CDCInfection

FDA warns companies to stop making MRSA claims

FDA is warning companies to stop making MRSA claims.

Methicillin-resistant Staphylococcus aureus (MRSA) bacteria can cause an infection that’s highly resistant to some antibiotics. MRSA cause infection after they enter the body through a cut or sore.

The US Food and Drug Administration has issued 4 warning letters to companies that manufacture and market over-the-counter (OTC) drug products (including hand sanitizers) that claim to prevent infection by MRSA.

The FDA warning letters target the following products.

  • Staphaseptic First Aid Antiseptic/Pain Relieving Gel
  • Safe4Hours Hand Sanitizing Lotion
  • Safe4Hours First Aid Antiseptic Skin Protectant
  • Dr. Tichenor’s Antiseptic Gel
  • CleanWell All-Natural Foaming Hand Sanitizer
  • CleanWell All-Natural Hand Sanitizer
  • CleanWell All-Natural Hand Sanitizing Wipes
  • CleanWell All-Natural Antibacterial Foaming Handsoap

The bottom line?

The warning letters explain that the companies are marketing these products in violation of federal law.

“MRSA is a serious public health threat,” said Deborah Autor, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “The FDA cannot allow companies to mislead consumers by making unproven prevention claims.”

4/21/11 20:26 JR

Hi, I’m JR

John Russo, Jr., PharmD, is president of The MedCom Resource, Inc. Previously, he was senior vice president of medical communications at, a complementary and alternative medicine website.